Nicox SA announced that its partner, Ocumension Therapeutics, has initiated a phase 3 clinical trial in China with Zerviate, the first and only topical ocular formulation of the antihistamine cetirizine, for the treatment of ocular itching associated with allergic conjunctivitis.
“Our teams worked very closely to obtain the Chinese Investigative New Drug approval for this trial and we are pleased that Ocumension has been able to capitalize on that with a swift initiation of the trial,” Gavin Spencer, Chief Business Officer at Nicox, said in a company news release. “This phase 3 trial, in addition to the data package used by the FDA for Zerviate in the United States, is expected to be sufficient to support a Chinese New Drug Application. The initiation of this trial keeps Ocumension on track with their launch plans for China.”
The phase 3 trial is a randomized, observer-masked, positive control, multi-center parallel clinical trial evaluating the safety and efficacy of Zerviate for Chinese patients with allergic conjunctivitis, and is expected to enroll approximately 296 patients at approximately 15 clinical centers.
Zerviate (cetirizine ophthalmic solution), 0.24%, is the first and only topical ocular formulation of the antihistamine cetirizine. Zerviate is exclusively licensed to Ocumension Therapeutics for the Chinese and South East Asian markets. Nicox may potentially receive development and sales milestones of up to US$19 million together with royalties of between 5% and 9% of net sales of Zerviate by Ocumension.
Zerviate, launched in the United States in March 2020 by Eyevance Pharmaceuticals, Nicox’s exclusive U.S. licensee, is also licensed to Samil Pharmaceutical in South Korea and to ITROM Pharmaceutical Group in the Gulf and Arab markets.